Data Management

• Paper and EDC trials
• CRF development
• Database design and setup
• Hosting and data warehousing of clinical trial project
• Data migration, mapping and imports
• Programming of edit checks and data cleaning
• MEDDRA and WHO data coding
• Direct data exports and transfers in various standardized formats
• Safety medical review
• IWRS and customized randomization
• CDISC standards compliance
• Compliance with FDA’s (21) CFR Part 11